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    Summary
    EudraCT Number:2018-003318-42
    Sponsor's Protocol Code Number:TAK-954-2004
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-02-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-003318-42
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in Patients Undergoing Large- and Small-Bowel Resection
    A.3.2Name or abbreviated title of the trial where available
    2004
    A.4.1Sponsor's protocol code numberTAK-954-2004
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1222-4784
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorTakeda Development Center Americas, Inc.
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTakeda Development Center Americas, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharmaceutical Company Limited
    B.5.2Functional name of contact pointTheresa White
    B.5.3 Address:
    B.5.3.1Street Address350 Massachusetts Avenue
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617444 3192
    B.5.6E-mailterry.white@takeda.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTAK-954
    D.3.2Product code TAK-954
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFelcisetrag
    D.3.9.1CAS number 916075-84-8
    D.3.9.3Other descriptive nameTAK-954
    D.3.9.4EV Substance CodeSUB188136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSterile concentrate
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Dose Ranging Study to Evaluate the Efficacy and Safety of 2 Dose Regimens of Intravenous TAK-954 for the Prophylaxis and Treatment of Postoperative Gastrointestinal Dysfunction in
    E.1.1.1Medical condition in easily understood language
    To determine the IMP decreases the duration of gastrointestinal (GI) dysfunction in patients undergoing major abdominal or laparoscopic-assisted surgeries that involve bowel manipulation.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10076042
    E.1.2Term Feeding intolerance
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of intravenous (IV) TAK-954 for accelerating the recovery of GI function postsurgery in patients undergoing open or laparoscopic-assisted partial small- or large-bowel resection.
    E.2.2Secondary objectives of the trial
    To determine efficacy and safety of preoperative dosing of IV TAK-954 relative to preoperative and postoperative regimens of up to 10 days of IV TAK-954 for accelerating the recovery of GI function postsurgery.
    To determine the relative efficacy and safety of 0.1 mg and 0.5 mg IV TAK-954 given either preoperatively alone or preoperatively and postoperatively compared with placebo of up to 10 days or resolution of GI dysfunction postsurgery for accelerating the recovery of GI function postsurgery.
    To determine the pharmacokinetics (PK) of TAK-954 in patients undergoing major abdominal surgery.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility is determined according to the following criteria before entry into the study:
    The subject is male or female (and not pregnant) and is at least 18 years old.
    The subject is scheduled to undergo a laparoscopic-assisted, or open partial small- or large-bowel, resection.
    The subject’s American Society of Anesthesiologists (ASA) physical status classification is ASA 1 to 3.
    A female subject of childbearing potential willing and agreeable to use highly effective contraception or sexual abstinence during the course of the study and up to 30-days posttreatment.
    E.4Principal exclusion criteria
    Any subject who meets any of the following criteria will not qualify for entry into the study:
    Has significant mechanical bowel obstruction that is not expected to resolve after the surgery, short bowel syndrome, pre-existing clinically significant GI motility disorder (eg, gastroparesis, scleroderma, chronic
    intestinal pseudo-obstruction), uncontrolled diabetes (glycosylated hemoglobin [HbA1c] >10%), has an active gastric pacemaker, or requires parenteral nutrition.
    Previous major abdominal surgery (eg, gastrectomy, gastric bypass, gastric sleeve, lap banding, Whipple, pancreatic resection, total/subtotal colectomy, hemicolectomy, extensive bowel resection).
    History of radiation therapy to the abdomen or pelvis.
    Scheduled to undergo any of the following surgeries: low anterior resection, total or subtotal colectomy,colostomy, ileostomy or reversal of stoma, or has a diagnosis that requires rectal resection (eg, tumors in the anorectum) and will likely require lower anterior resection surgery. Subjects with planned surgery for which there is no anticipated significant rectal resection and is, therefore, likely to preserve anorectal function and continence postsurgery, will likely be eligible for inclusion in the study if they meet all the study inclusion/exclusion criteria (eg, subjects with lesions not involving the rectum [sigmoid colon and above]).
    Has pre-existing hepatic disease that meets Child-Pugh Class B (moderate; total score 7 to 9 points) or C (severe;total score 10 to 15 points).
    Has alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3×upper limit of normal (ULN), or total bilirubin >2 × ULN.
    Has an estimated glomerular filtration rate (GFR) <30 mL/min.
    Has received alvimopan, erythromycin, prucalopride, metoclopramide, domperidone, cisapride, mosapride, renzapride, or azithromycin in the 24 hours prior to starting the study drug.
    Has a resting heart rate of < 50 beats per minute (bpm).
    Has clinically significant electrocardiogram (ECG) abnormalities indicative of cardiac conduction abnormality or acute cardiac instability, as determined by the investigator at screening; more than first degree atrioventricular (AV) block; >5 beats of nonsustained ventricular tachycardia (VT) at a rate >120 bpm) or ECG changes consistent with acute myocardial ischemia or infarction.
    Has a QT interval with Fridericia correction method (QTcF) interval ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events at screening. The records of subjects with bundle branch block and a prolonged QTcF should be reviewed by a medically
    qualified person in consultation with the medical monitor and the sponsor for potential inclusion.
    Had acute myocardial infarction or ischemia within the past 12 months. Subjects with increased cardiac risks for surgery including coronary artery disease or prior myocardial infarction and evidence of reduced left ventricular function or history of angina should be assessed by the investigator for stability and control of their cardiac condition and risk of surgery, and excluded if in the investigator’s opinion, participation in the study is not considered appropriate. The sponsor should be consulted if subjects with these conditions are considered by the investigator to be acceptable.
    Had pulmonary embolism, deep venous thrombosis, or mechanical ventilation for any medical condition within the past 12 months. Subjects with a history of multiple venous thrombosis or pulmonary embolic events, history of a hypercoagulable condition, history of severe exacerbation for chronic obstructive pulmonary disease or evidence of pulmonary hypertension should be assessed by the investigator for stability and control of their conditions and risk of surgery, and excluded if in the investigator’s opinion, participation in the study is not considered appropriate. The sponsor should be consulted if subjects with these conditions are considered by the investigator to be acceptable.
    Scheduled for abdominal surgery that is classified as emergency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is time from the end of surgery to resolution of upper and lower GI function (ie, time to tolerance of solid food [defined as first occurrence of no vomiting or no clinically significant nausea for 1 calendar day after a solid meal] and time to first spontaneous bowel movement, whichever occurs later) up to Day 10 postsurgery.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 - 5 days
    E.5.2Secondary end point(s)
    The secondary endpoints for this study are:
    Time from the end of the surgery (time the incision is closed) until ready for discharge (defined as the time until the subject presents effective intestinal transit (spontaneous bowel movement), tolerates solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal, has satisfactory pain control with oral analgesics, and is medically stable/free of complications).
    Time from the end of surgery until the discharge order is written.
    Time from the end of the surgery to discharge from hospital.
    Time from end of surgery to tolerance of solid food (defined as first occurrence of intake of solids without vomiting or clinically significant nausea for 1 calendar day after a solid meal) up to Day 10 postsurgery.
    Time from end of surgery to first spontaneous bowel movement (defined as a stool not induced by the use of enemas or laxatives) up to 10 days postsurgery.
    Percent of subjects with POGD ≥5 days defined as subjects unable to tolerate solid foods, take anything by mouth, or requiring insertion or reinsertion of NG at or after 5 days postsurgery.
    Percentage of subjects requiring insertion of NG tube postsurgery, for drainage and symptom relief in case of persistent nausea and vomiting postsurgery up to Day 24 postsurgery (up to 10-day treatment period plus 14-day observation period post last dose for recurrence of symptoms).
    Time from end of surgery to first flatus up to Day 10 postsurgery.
    Observed plasma concentration of TAK-954 at the end of infusion on Day 1.
    E.5.2.1Timepoint(s) of evaluation of this end point
    4 - 5 days
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Germany
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The overall study ends when the last subject completes the last
    planned or follow-up visit/interaction associated with a planned visit
    (this can be a phone contact), discontinues from the study, or is lost to
    follow-up (ie, the investigator is unable to contact the subject).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 205
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 375
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Study drug will not be available upon completion of the subject's participation in the study. The subject should be returned to the care of a physician and standard therapies as required.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusRestarted
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